NCT04413448

Brief Summary

Objective: To evaluate the performance of CT parameters (SBAC-L1 and fractal analysis) compared to BMD (gold standard) to detect vertebral fractures in rheumatoid arthritis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
Last Updated

June 4, 2020

Status Verified

May 1, 2020

Enrollment Period

Same day

First QC Date

May 7, 2020

Last Update Submit

May 28, 2020

Conditions

OsteoporosisRheumatoid ArthritisVertebral Fracture

Outcome Measures

Primary Outcomes (2)

  • Performance of SBAC-L1 to detect the presence of vertebral fracture on CT

    4 months

  • Performance of FD-L1 to detect the presence of vertebral fracture on CT

    4 months

Secondary Outcomes (3)

  • ROC curves to determine fracture thresholds to detect vertebral fractures on SBAC-L1( in Hounsfield Unit)

    1 month

  • Correlation between demographic , clinical, biologic and treatments and the presence of bone fragility (vertebral fracture, SBAC-L1, FD-L1)

    4 month

  • ROC curves to determine fracture thresholds to detect vertebral fractures on FD-L1

    1 month

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Rheumatoid arthritis patients followed from 2009 to 2019 in Nancy University hospital who met the 2010 ACR/EULAR criteria for RA and examined using thoraco-abdomino-pelvic CT (TAP-CT) and BMD (spine, hip) within a period of up to 2 years were included.

You may qualify if:

  • Rheumatoid arthritis patients followed from 2009 to 2019 in Nancy University hospital who met the 2010 ACR/EULAR criteria for RA
  • Thoraco-abdomino-pelvic CT (TAP-CT) and BMD (spine, hip) within a period of up to 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Nancy

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France

Location

Related Links

MeSH Terms

Conditions

OsteoporosisArthritis, RheumatoidSpinal Fractures

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesArthritisJoint DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpinal InjuriesBack InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Damien Loeuille, MD-PhD

    +33662436967

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2020

First Posted

June 4, 2020

Study Start

January 1, 2020

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

June 4, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)